Omeeta Shah

• Overviewed Individual Case Safety Reports (ICSRs) case processing, performed quality check of safety reports including MedDRA coding, Narrative quality, case reportability, casuality assessment and triaging submission per safety report submission timeline. • Performed both Expedited and periodic Safety reports submissions to RA, EC and PI. • Proficient with IRB/EC web portals, investigator reporting systems (Lifesphere /WCG Trifecta) and global regulatory submission systems and its requirement • Processed SUSAR, DSUR, PSUR, Line Listings (6MLL,2MLL) and ASR by gathering all required information for each country submission with applicable local regulations. • Responsible for authoring and maintaining of Expedited Safety Reporting Plans (ESRPs), and associated regulatory documents and safety reporting section of Safety Management Plans (SMPs) per study contract • Reviewed safety section of IBs, ICFs, MMPs • Responsible for tracking all Expedited and Periodic safety submissions and maintaining all submission evidence and made them available to study team members. • Collaborated with safety database administrators for system maintenance and validation. • Collaborated with the clinical team in preparing ASR reports, CTMS queries, SIV updates, EDC queries, system login credentials to site users, and PI compliance issues. • Integrated CTMS system (Veeva/Activate) with safety reporting system so that team start with safety submission per country approval dates • Well versed with CTD and CTR requirement for EU submissions, strong knowledge of US FDA, Regulatory authorities in APAC and Canada regions • Ensured compliance with ICH-GCP, FDA, EMA, and global health authority regulations, adapting workflows to evolving local requirements. • Proficient in Powe BI, Excel for analysis and compliance findings • Effectively follow-up with team on pending queries, responses and ensures workflow steps are completed in accordance with standard procedures and within timelines.

• ICSR case processing, MedDRA coding, Auto and Manual Narrative Writing and preparing SUSAR and SAE safety reports (7/15day reports) • Reviewed and processed Clinical Trial reports, Post marketing reports, patient supported solicited reports and literature-based reports • Well-versed with Argus and Lifesphere’s ARISg safety data systems and able to create E2B R2 and R3 XMLs, CIOMS-II, line listings (6MLL/2ML) etc per local regulations. • Raised and managed queries in Medidata system and supported investigator site staff in resolving data-related issues efficiently • Performed data quality checks in safety databases, ensuring accuracy, consistency, and completeness. • Led end-to-end review of SAE/SUSAR case processing and reporting, performing QC and compliance verification of submissions against client SOPs, regulatory requirements, and study protocols. • Collaborated with medical reviewers to analyze safety signals and assess seriousness, expectedness, causality, and drug-related toxicities. • Performed study start-up and close-out activities, coordinate file returns and system updates • Monitored KPIs (e.g., case volume, compliance), and prepare status reports for Project management • Responsible for designing and updating Safety Management Plans (SMPs) and its addenda, reviewing safety section in Medical Management Plans (MMPs) and company SOPs, incorporating compliance findings to strengthen vendor and team adherence to contractual deliverables. • Actively supported and prepared for internal and external audits, presenting compliance data and risk assessments to auditors and clients. • Conducted reconciliations between clinical and safety databases at an agreed intervals to identify discrepancies, ensure data accuracy, and maintain compliance documentation for audit readiness. • Identify and investigate quality deviations (QE’s); implement and maintain CAPAs.

• Responsible for case intake, duplicate check, and case book-ins for serious adverse events for clinical trial and post marketing cases • Classifying events as SUSAR, NON-SUSAR and others for reporting purposes • Data entry of individual case safety reports into the Argus safety database. • Responsible for reviewing and evaluating AE case information to determine required action following internal policies and procedures. • Conduct full data entry including medical coding and safety narrative. • Coding all medical history, events, drugs /procedures/indications, and laboratory tests according to the appropriate dictionary (MedDRA, WHO-DD) • Responsible for writing medically relevant safety narrative of cases and checking the completeness and accuracy of the data entered in the various fields. • Adhere to company SOPs and global/local regulatory guidelines ICH-GCP.. • Collaborate with safety physicians for signal detection and risk evaluation documentation. • Review and process literature-based AE reports; support regulatory reporting including PSURs, DSURs, line listings, and annual safety reports.

• Working as Clinical Research Coordination in Phase 2 Clinical Trial of Monet Study. • Working as documentation coordinator for MD office software for entering patient personal data , insurance information. • Maintained all IRB submissions and approved documents as necessary. • Served as liaison at the Site, CRA and PI. • Documenting clinical data in CRF in ORACLE software used by pharma company. • Completed, reviewed and maintained source documents and CRFs clinical trials. • Participated in protocol review or study procedure planning meeting. • Taken Oracle training thereby optimizing accurate and complete data captured at each subject’s Visits. • Design and created subject tracking charts to ensure timely data entry and subject visit scheduling. • Using Dyopsis software to perform ERG. • Documenting patient history and chief complaints. • Performing preliminary eye exam and ordering necessary diagnostic procedures • Keeping all test data ready to review by ophthalmologist • Obtaining patient consent for various invasive procedures and filing them in appropriate patient records. • Patient counseling/ information on various procedures and test. • Ordering prescription drugs for patients, providing substitutes for prescribed drugs. • Keeping a track of all drugs and medications and storing them at appropriate temperature. • Autoclaving all small minor surgical instruments and storing. • Following standard office procedures, GCP, adhere to HIPPA regulation. • Maintaining patient records/ data at appropriate place. • Coordinating between patients, doctors and pharmacy's calls. • Performing Administrative work that includes patient scheduling, reminding calls to patients, checking office inventories and ordering. Helping other office staff and team player

Junior Consultant optometrist duties include history taking, refraction, anterior segment evaluation with slit lamp. well versed with visual field testings, HRT, Fluroscein and ICG angiography, contact lens, LVA, Binocular vision Theraphy etc.. use to make PPT for ophtalmologist, use to prepare Medical summary for patients, patient counselling, obtaining surgical inform consent, ophthalmic scribe.

• Conducted comprehensive eye examinations and diagnosed a range of ocular conditions, including glaucoma, cataracts, and retinal disorders. • Prescribed corrective lenses and coordinated with ophthalmologists for advanced or surgical care referrals. • Performed specialty contact lens fittings and delivered myopia management solutions for pediatric patients. • Supervised and trained support staff in diagnostic procedures, equipment use, and patient care standards.